1. Field of the Invention
The invention relates to surgical stabilizer devices and methods. More specifically, the invention relates to surgical devices and methods for achieving a desired configuration of one or more anatomical structures, e.g. by suction or inflation, and then optionally for deploying e.g. a helical staple to stabilize the anatomical structure in the desired configuration, or otherwise stabilizing the structure. Embodiments of the invention can be used in the treatment of incontinence, coronary artery blockage, and blockages or strictures in other anatomical structures. Additionally, embodiments of the invention also can be used to create anastomoses between anatomical structures, and/or to create or reverse functional vasectomies, tubal ligations and the like. Aspects of the invention are particularly (though not exclusively) applicable in minimally invasive surgical settings.
Aspects of the invention provide dilation and/or constriction of anatomical structure, and subsequent stabilization, all while maintaining the lumen of the anatomical structure free of stents or other foreign bodies. Patients thus are believed better able to tolerate the treatments and devices described herein than with typical, invasive, intraluminal stents or the like.
Other fields in which embodiments of the invention can be used will become apparent upon reading the remainder of this patent application.
2. Description of Related Art
Commonly assigned U.S. Pat. No. 6,149,667, incorporated herein by reference, provides an implanted support for e.g. the urethral neck of the bladder, substantially preventing urinary leakage caused by transmission of intra-abdominal pressure pulse waves. The support is implanted in a straightforward manner without the significant complexity and invasiveness associated with previously known surgical techniques, and thus provides significant advantages. Pelvic trauma is dramatically reduced. Embodiments of the invention disclosed in the patent can be used in the treatment of stress incontinence, and other types of incontinence, in both males and females.
First-described embodiments of the invention relate to the treatment of incontinence. One particular form of incontinence, stress incontinence, often is caused by weakened muscles in the pelvic floor. Without adequate pelvic support, the bladder and proximal end of the urethra tend to sag, the bladder neck dilates, the proximal urethra widens, and the urethra as a whole shortens. Normal flow resistance from the bladder neck and the urethral sphincter decreases, causing leakage upon increase in intra-abdominal pressure that might be due to coughing, for example. FIG. 1 roughly illustrates three anatomical configurations with respect to pelvic floor 2: normal anatomy 4, descended bladder/urethra 6, and widened bladder neck/shortened urethra 8. FIG. 1 is adapted from Mundy, A. R., ed., Urodynamicsxe2x80x94Principles, Practice and Application, 1984, p. 229. The Urodynamics text is incorporated by reference herein in its entirety.
Embodiments of the invention provide a permanent implanted support for an anatomical structure, e.g. the urethral neck of the bladder, a coronary artery or other vascular structure, fallopian tubes, vas deferens, stomach, esophagus, intestine, bile duct, rectum, small bowel and/or other anatomical structures. Embodiments of the invention can cause both dilation of anatomical structures, in the manner of e.g. traditional angioplasty procedures, and/or cause constriction or narrowing of anatomical structures. The support is implanted in a straightforward manner without the significant complexity and invasiveness associated with known surgical techniques. The support can remain completely outside the lumen of the anatomical structure if desired. Trauma to the patient is dramatically reduced.
According to particular embodiments of the invention, an apparatus for treatment of anatomical structure having a lumen comprises a pressure differential device constructed to create a pressure differential with respect to the lumen of the anatomical structure, to cause movement of the anatomical structure to a desired configuration for treatment. The apparatus further comprises a stabilizing device, operably coupled with the pressure differential device, to stabilize the anatomical structure in the desired configuration. The pressure differential device can be constructed to create a negative and/or positive pressure differential relative to luminal pressure of the anatomical structure. Particular embodiments of pressure differential device include a vacuum source, suction source and/or positive pressure source with appropriate fluid communication and coupling, and cause constriction of the anatomical structure to the desired configuration and/or dilation of the anatomical structure to the desired configuration. A positive pressure differential device can include an inflatable balloon. The pressure differential device can be constructed and arranged to aid in performing an angioplasty procedure in a coronary artery, tubal ligation or reversal thereof, vasectomy or reversal thereof, incontinence treatment, stomach size reduction, and treatment of varicose veins, to name a few examples.
A stabilizing device according to embodiments of the invention comprises structure for applying a holding device to the anatomical structure, the holding device being constructed to remain applied to the anatomical structure after removal of the apparatus from the vicinity of the anatomical structure. The stabilizing device according to an embodiment of the invention also can comprise the holding device itself. According to particular embodiments, the holding device remains completely outside of the lumen both during and after the surgical procedure. The lumen of the anatomical structure is reduced and/or enlarged when the anatomical structure is in the desired configuration. A stabilizing device according to a particular embodiment comprises a helical staple that is applied to the anatomical structure while it is in the desired configuration, to hold the desired configuration after removal of the apparatus.
One particular pressure differential device comprises a set of suction apertures fluidly coupled to a suction source, the set of suction apertures constructed and arranged to cause movement of the anatomical structure to the desired configuration. The set of suction apertures can be a first set of suction apertures, the pressure differential device further comprising a second set of suction apertures fluidly coupled to a suction source. The first and the second sets of suction apertures can be constructed and arranged to cause relative movement of two portions of the anatomical structure toward each other to form an anastomosis. At least one of these sets of suction apertures can be constructed to move toward the other of the sets of suction apertures to form the anastomosis, optionally upon movement by an operator simultaneously with application of suction via the suction apertures. A plurality of suction apertures can be constructed and arranged to cause relative movement of two portions of the anatomical structure toward each other to facilitate formation of the anastomosis.
A stabilizing device according to a particular embodiment of the invention includes a surgical fastener and an applicator for applying the surgical fastener to the anatomical structure. A generally cylindrical member can be operably coupled with the stabilizing device and the pressure differential device, the surgical fastener, the applicator and at least one of the suction apertures being disposed around the generally cylindrical member. The generally cylindrical member can be a first generally cylindrical member, the apparatus further comprising a second generally cylindrical member operably coupled with the stabilizing device and the pressure differential device. At least another of the suction apertures is disposed around the second generally cylindrical member, according to one embodiment, the first generally cylindrical member and the second generally cylindrical member being generally concentric and disposed for relative movement between them.
A guide can be operably coupled with the stabilizing device to guide movement of the anatomical structure. According to one embodiment, the guide is moveable between a deployed configuration and a non-deployed configuration, generally pivoting or bending outwardly during movement between the two configurations. The guide in the deployed configuration can define a generally V-shaped or conical opening for receiving anatomical structure therein. The guide can define indentations for at least partially receiving a helical staple as a part of the stabilizing device. The guide also can define a general cone shape when in the deployed configuration. Particular embodiments of the invention are especially constructed for at least one of vascular closure, wound closure, and ligation of gastrointestinal hemorrhage.
Other embodiments of the invention are particularly constructed to cause e.g. a fallopian tube or vas deferens to collapse or close tightly on itself upon application of negative pressure. A stabilizing device according to this embodiment comprises a helical staple and helical-staple applicator, the applicator applying the helical staple to the anatomical structure after the anatomical structure has closed upon itself. A wire also can be provided, constructed to deploy within the lumen of the anatomical structure to damage the anatomical structure before it is stabilized by the stabilizing device. The wire can be a resistive wire for applying heat to the anatomical structure.
According to another embodiment, the apparatus further comprises a cutting device, operably coupled with the pressure differential device and the stabilizing device, for cutting the anatomical structure. The stabilizing device also can comprise repair material, and/or structure for applying the repair material to the anatomical structure in the vicinity of the cut anatomical structure. The repair material remains applied to the anatomical structure after removal of the apparatus from the vicinity of the anatomical structure, according to one embodiment.
According to another specific embodiment, apparatus for treatment of anatomical structure having a lumen comprises a movement device constructed to cause movement of the anatomical structure to a desired configuration for treatment, and a stabilizing device, operably coupled with the movement device, constructed to stabilize the anatomical structure in the desired configuration. The movement device can comprise a cutting device for cutting the anatomical structure. The stabilizing device can comprise structure for applying repair material to the anatomical structure in the vicinity of the cut anatomical structure. The repair material can remain applied to the anatomical structure after removal of the apparatus. The stabilizing device further can comprise a surgical fastening agent, such as one defining a helical shape or comprising a helical staple, to hold the repair material in place with respect to the anatomical structure. Particular apparatus embodiments according to the invention are constructed and arranged for use in a blocked coronary artery.
The stabilizing device can comprise a helical staple and an advancement member for contacting and advancing the helical staple into the anatomical structure after the cutting device has cut the anatomical structure. The helical staple is constructed to hold repair material in place on the anatomical structure. According to one embodiment, a single motion of the operator of the apparatus is sufficient to both cut the anatomical structure and to apply the repair material. A cutting device advancement mechanism can advance the cutting device relative to the anatomical structure, e.g. a threaded screw. The anatomical structure can be cut and the repair material applied to the anatomical structure generally simultaneously, according to embodiments of the invention. As with previous embodiments, the stabilizing device can be constructed to remain completely outside of the lumen. A suction device applies suction in the vicinity of the anatomical structure and/or a positive pressure device applies positive pressure in the vicinity of the anatomical structure, according to embodiments of the invention.
According to another aspect of the invention, an apparatus for facilitating treatment of anatomical structure having a lumen comprises a pressure differential device constructed to cause movement of the anatomical structure to a desired, generally stabilized configuration by creating pressure differential from within the lumen, the desired configuration being suitable for further stabilization or treatment, the apparatus further comprising a member constructed to support the pressure differential device from within the lumen. The pressure differential device can comprise a suction device for drawing the anatomical structure toward the pressure differential device and into the desired configuration.